Chlorhexidine Gluconate 0.12% Oral Rinse

INDICATIONS AND USAGE: Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS .

DOSAGE AND ADMINISTRATION: Chlorhexidine gluconate oral rinse therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine gluconate oral rinse should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing. Usual dosage is 15 ml (1 tablespoon) of undiluted chlorhexidine gluconate oral rinse. Patients should be instructed to not rinse with water or other mouthwashes, brush teeth or eat immediately after using chlorhexidine gluconate oral rinse. Chlorhexidine gluconate oral rinse is not intended for ingestion and should be expectorated after rinsing.

CONTRAINDICATIONS: Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

ADVERSE REACTIONS: The most common side effects associated with chlorhexidine gluconate oral rinses are: 1) an increase in staining of teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception, see WARNINGS and PRECAUTIONS . Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1%. Among post marketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinse. There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse.

DESCRIPTION: Chlorhexidine Gluconate 0.12% Oral Rinse, USP is an oral rinse containing 0.12% chlorhexidine gluconate (1, 11-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, peppermint flavor, sodium saccharin, and FD&C Blue No. 1. Chlorhexidine gluconate oral solution is a near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its molecular formula is C 22 H 30 C l2 N 10 ·2C 6 H 12 O 7 , the molecular weight is 897 and its chemical structure is: "Image Description"

OVERDOSAGE: Ingestion of 1 or 2 ounces of chlorhexidine gluconate oral rinse by a small child (~10 kg body weight) might result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces of chlorhexidine gluconate oral rinse is ingested by a small child or if signs of alcohol intoxication develop.

HOW SUPPLIED: Chlorhexidine Gluconate 0.12% Oral Rinse, USP is supplied as a light blue color clear solution in 4-ounce (120 ml) [NDC 62135-649-41] and 16 ounce (473ml) [62135-649-47] child-resistant bottles, 15 mL Unit Dose Cup [62135-650-51] and 20 Unit Dose Cups 15 mL each [62135-650-24]. STORE at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled Room Temperature]. Dispense in original container or in amber glass bottles. Rx only Keep out of reach of children. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71503 Rev. 05/2024